Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020988
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTONIX IV | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/06/2004 | ORIG-27 | Approval | Supplement | STANDARD |
Label is not available on this site. |
||
| 03/22/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020988s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020988Orig1s069ltr.pdf | |
| 03/04/2022 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020988s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020988Orig1s064ltr.pdf | |
| 11/27/2020 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020988s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020988Orig1s062ltr.pdf | |
| 04/25/2019 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020988s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020987Orig1s055; 020988Orig1s061; 022020Orig1s017ltr.pdf | |
| 06/07/2018 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020988s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf | |
| 07/06/2017 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020988Orig1s059ltr.pdf | |
| 12/06/2017 | SUPPL-58 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022020s014, 020987s052, 020988s058ltr.pdf | |
| 12/20/2017 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf | |
| 10/24/2016 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/20988Orig1s054ltr.pdf | |
| 11/09/2015 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020988Orig1s052ltr.pdf | |
| 11/05/2014 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020988Orig1s048ltr.pdf | |
| 03/04/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2012 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988s045ltr.pdf | |
| 09/28/2012 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988Orig1s044ltr.pdf | |
| 05/20/2011 | SUPPL-43 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s043ltr.pdf | |
| 12/07/2011 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s042ltr.pdf | |
| 06/07/2011 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s041ltr.pdf | |
| 09/03/2010 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020988s040ltr.pdf | |
| 12/20/2007 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf |
| 08/03/2005 | SUPPL-32 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s032ltr.pdf | |
| 08/02/2005 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s031ltr.pdf | |
| 10/28/2004 | SUPPL-29 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s029ltr.pdf |
| 11/18/2004 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s028ltr.pdf |
| 12/06/2004 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s027ltr.pdf | |
| 04/02/2004 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr025ltr.pdf | |
| 04/02/2004 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988scf024ltr.pdf | |
| 01/02/2004 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr021ltr.pdf |
| 01/09/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr020ltr.pdf | |
| 05/05/2004 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr019ltr.pdf | |
| 11/18/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr017ltr.pdf | |
| 10/24/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr016ltr.pdf |
| 03/05/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr015ltr.pdf | |
| 12/04/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/2002 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf |
| 05/14/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr007ltr.pdf |
| 06/08/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/19/2001 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20988s3ltr.pdf | |
| 09/27/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020988s069lbl.pdf | |
| 03/04/2022 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020988s064lbl.pdf | |
| 11/27/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020988s062lbl.pdf | |
| 04/25/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020988s061lbl.pdf | |
| 06/07/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020988s060lbl.pdf | |
| 12/20/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s055lbl.pdf | |
| 12/06/2017 | SUPPL-58 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf | |
| 07/06/2017 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s059lbl.pdf | |
| 10/24/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf | |
| 12/19/2014 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf | |
| 12/12/2013 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf | |
| 09/28/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf | |
| 05/10/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf | |
| 12/07/2011 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf | |
| 06/07/2011 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf | |
| 05/20/2011 | SUPPL-43 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf | |
| 09/03/2010 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf | |
| 08/03/2005 | SUPPL-32 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf |
| 08/02/2005 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf | |
| 12/06/2004 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf | |
| 05/05/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf | |
| 04/02/2004 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf | |
| 04/02/2004 | SUPPL-24 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf | |
| 03/05/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf | |
| 01/09/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf | |
| 11/18/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf | |
| 10/19/2001 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf | |
| 03/22/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf |
PROTONIX IV
INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213778 | ASPIRO |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 216171 | BE PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 079197 | EPIC PHARMA LLC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205675 | EUGIA PHARMA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204400 | GLAND PHARMA LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209524 | HANGZHOU ZHONGMEI |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 214680 | KNACK |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215860 | MEITHEAL |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090296 | SANDOZ |
| PROTONIX IV | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 020988 | WYETH PHARMS |